The GlucoWatch (TM) by Cygnus, Inc.From a press release dated First Quarter, 1996

Overview

According to the American Diabetes Association (ADA), approximately seven million Americans have been diagnosed with diabetes. Diabetes can lead to severe complications over time, including blindness, loss of kidney function and peripheral neuropathy, causing pain to the arms and legs and potentially requiring amputation. The ADA estimates that the complications aring from diabetes cost the U.S. health care system in excess of $45 billion in 1992. These complcations are largely the consequence of years of poor management of glucose levels by patients with diabetes. Results of the Diabetes Control and Complications Trial (DCCT) shows that frequently monitored blood glucose levels and insulin injections could prevent many of the long-term complications of diabetes.

Patients with diabetes measure blood glucose levels to enable them to adjust their diet and use of insulin to prevent these complications. Currently, diabetic patients are required to stab their fingers with a lancet, draw blood, place a drop of blood on a glucose reagent strip, then place the strip in an instrument which provides a blood glucose reading. Diabetic patients test their blood glucose levels on average less than half as often as recommended, largely due to the pain and disruption of daily life associated with the prevailing "finger stab" method.

Market

The worldwide market for glucose monitoring products exceeded US$1.5 billion in 1994, and has grown at about 14% annually for the past few years. The U.S. comprises about 59% of this market. Approximately 90% of the 1994 sales were related to displosable glucose reagent strips for finger stab monitoring. Studies have shown that 30% of all patients with diabetes, or about 2 million people, constitute 86% of the tests in the U.S. The successful development of a painless, continuous glucose monitoring device has the potential to expand this market by meeting needs not served by the finger stab technology.

Barriers to Frequent Testing

Currently, the average diabetic patient tests his/her blood glucose levels less than twice a day. Research has shown that the primary barriers to more frequent glucose testing among patients with diabetes using the prevailing "finger stab" method include:

Fear of hypoglycemia which can result from tighter glucose level control

Benefits of Continuous Glucose Monitoring

Results of the Diabetes Control and Complications Trial (DCCT) showed that frequent self-testing of glucose and insulin adminstration resulted in reductions in diabetes-related complications up to 70%. The DCCT trial also showed that increased hypoglycemia was associated with more frequent analysis and injection, suggesting that only continuous evaluation of blood glucose provides the potential to fully control side-effects, while minimizing the potential risk of hypoglycemia.

Cygnus' GlucoWatch (TM)

Cygnus is developing a monitoring device called the GlucoWatch (TM), which is worn like a wristwatch. The GlucoWatch (TM) is designed to extract and measure glucose levels and trends, and offers a combination of features not available in currently marketed devices including:

Glucose molecules are collected in a small, daily disposable GlucoPad (TM), which adheres to the skin and is connected to a sensor and covered by the GlucoWatch (TM). The collected glucose triggers an eletro-chemical reaction with a reagent in the GlucoPad (TM), generating an electric current.

The sensor measures the electrons and a custom application specific integrated circuit (ASIC) in the GlucoWatch (TM) equates the level of electron emission to a concentration of glucose in the patient's blood.

A control mode commands the sensor to measure glucose levels at 30 minute intervals, providing readings throughout the day and night.

The GlucoWatch (TM) displays the most recent readings and trends at the push of a button. Its electronic memory capabilities permit the retrieval and downloading of data, allowing longer-term trend analysis for better disease management.

Development Stages

Cygnus developed the basic GlucoWatch (TM) technology from 1988 to 1994, resulting in the creation of an initial prototype.

Initial Prototype

Technical feasibility was established during this stage by proving the ability to

extract glucose painlessly,

track high and low levels of blood glucose, and

achieve levels of clinical accuracy and reproducibility which are substantially equivalent to those obtained with already approved finger stab devices.

Cygnus' research paper entitled "Measurement of glucose in diabetic subjects using non-invasive transdermal extraction" was published on November 1, 1995 in Nature Medicine. The results presented confirm that glucose collected non-invasively through the skin correlates to the concentration of glucose in the blood.

Commercial Prototype

Cygnus is currently optimizing, miniaturizing and integrating the various components of the GlucoWatch (TM). When this has been achieved, additional clinical studies will be conducted, and after confirming that the miniaturized device can achieve a level of clinical accuracy and reproducibility comparable to those achieved with commercially available products, larger scale clinical trials will be conducted to support a medical device submission to the FDA.

Marketing Collaboration

Becton Dickenson, the global market share leader in insulin syringes, has marketing and distribution rights worldwide (not including Japan and Korea). A second partner will be selected for Japan and Korea.

Pricing

Our objective is to price the GlucoWatch (TM) and GlucoPad (TM) so that it is affordable for the majority of diabetics. Pricing has not been finalized, however the average daily price of the GlucoPad (TM) could be US$3.00 or more. The GlucoWatch (TM) will probably be priced below US$400 and should last about four years.

Last Updated: Thursday February 27, 2014 19:28:21
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